The question remains: is it unethical to not properly evaluate a treatment before its use in patients, especially those whose physiology is distinctly different from the initial adult test population?
Seoul, Korea; San Francisco, California (PRWEB) June 17, 2015
Bioanalytical Laboratory BioCore (http://www.bio-core.com), Korea’s most established bioanalytical Contract Research Organization, announced today that it will be sponsoring Dr. Le Thuy Vuong in San Francisco to speak to Microdosing clinical designs for addressing pediatrics. The forum is The American College of Clinical Pharmacology (ACCP)’s 2015 Global Conference on Clinical Pharmacy: “Microdosing in Drug Development: A Range of Clinical Trial Designs and Applications”. The event is to occur in San Francisco at the Westin St. Francis, September 26.
The Microdosing workshop, chaired by Drs. Tal Burt and Saskia N. de Wildt will offer cutting-edge educational programming presented by some of the world’s leading practitioners and researchers. Some of the objectives of the workshop are to recognize the role and promise of microdosing in accelerating drug development with a special focus on pediatrics and vulnerable populations.
Dr. Vuong is a recognized authority on using Accelerator Mass Spectrometry or AMS, for elucidating the metabolism of pharmaceuticals in pediatrics. The work Dr. Vuong has pioneered represents the first application of radiocarbon-based tracers to investigate the appropriate dosing schedules of ursodiol in the treatment of neonatal cholestasis. Dr. Vuong’s work is significant in that it applies microdosing and microtracing concepts to neonates using the exquisitely sensitivity radiocarbon detection technology known as Accelerator Mass Spectrometry or AMS. Prior to her pioneering work, sensitive subpopulations such as neonates had not benefited from radiolabeled tracer research due to concerns over ionizing radiation using traditional methods of detection.
“Our work, in collaboration with Dr. Arlin Blood at Loma Linda University and other researchers, was designed to study the off-label use of drugs such as ursodiol directly in neonates and infants using accurate tracer techniques”, reports Dr. Vuong. “We validated the AMS platform as the single tool that can deliver high density pharmacokinetic and mass balance information using levels of radioactivity that do not differ from those found in a few days of normal diet”.
The off-label use of drugs in pediatrics is an issue of growing scientific and ethical concern. Dr. Vuong’s work describes a means for the study of these drugs safely in neonates in ways not previously possible. Single drops of blood drawn from heel sticks can be taken in series to define the Absorption, Metabolism, Distribution, and Elimination of drugs directly in this sub-population at minimal risk.
Dr. Vuong brings her set of skills and experience to BioCore, According to Dr. Hyung-Sik Choie, President of BioCore, the skills Dr. Vuong brings to BioCore will be part of its active global development plan to acquire expertise and know-how in order to implement novel clinical testing methods at BioCore. “We are pleased to retain Dr. Vuong and excited to expand our AMS offerings into the critical area of pediatric drug development” states President Choie. “This is only the beginning of our growth into a global leader of unique, and advanced bioanalytical services – Korea is an emergent powerhouse and BioCore is one the pillars of efficient drug development”.
More about ACCP in September 26, 2015
Dr. Vuong speaks at the following times: Workshop 3 on Microdosing in Drug Development, Saturday, 9/26/15.
1:50 pm – 2:20 pm: Pharmaceutical Industry Clinical Pharmacology Perspective on Microdosing
4:40 pm – 5:00 pm – Design your Own Microdosing Study: Choose from Five Scenarios.